EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
K240850Philips Ultrasound LLC · cleared 2024-04-24 · product code IYN · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“The purpose of this Special 510(k) Pre-Market Notification is to introduce the Smart View Select (SVS) software application onto the EPIQ Series Diagnostic Ultrasound Systems and to introduce the Segmental Wall Motion software application onto both the EPIQ and Affiniti Series Diagnostic Ultrasound Systems. No hardware changes to the EPIQ or Affiniti systems are required when using SVS or SWM, and existing, cleared Philips TTE transducers are used with these software applications.”
source quote (p.6)
“The classification is based on a Deep Learning AI interface engine; the selection is a non-AI algorithm that considers the view classification and image depth to select the optimal set of images. The SWM algorithm uses 3 apical views (A4C, A2C and A3C) and performs border detection and tracking to identify each of the LV segments based on the three views. The application then provides segmental wall motion scores for each of the 17 segments of the LV by using machine learning algorithms and an overall wall motion score index (WMSI) is calculated as the average of the segmental scores.”
source quote (p.10)
“Not applicable - does not contain functionality for optimal triplet selection”
Validation studies (2)
Retrospective clinical
sample size not stated
endpoints: agreements between GLS/EF measured via manual clip selection and compared to SVS clip selection and GLS/EF output using AutoStrain LV software. Agreement was measured as correlation for each output, separately for GLS and EF (co-primary endpoints).
standards: IEC 62304 Medical device software - Software life cycle processes, 2006 + A 2015, IEC 62366-1 Medical devices - Part 1: Application of usability engineering to medical devices Edition 1.1 2020-06 CONSOLIDATED VERSION, ISO 14971 Medical devices- Application of risk management to medical devices, 2019
Retrospective clinical
sample size not stated
endpoints: assess the use of Segmental Wall Motion (SWM), a machine learning-based feature in quantification of Wall Motion Score Index (WMSI) in transthoracic (TTE) ultrasound clips... compared to LVivo SWM (DiA Imaging Analysis) application (ground truth) in the quantification of WMSI for the same subjects' exams.
standards: IEC 62304 Medical device software - Software life cycle processes, 2006 + A 2015, IEC 62366-1 Medical devices - Part 1: Application of usability engineering to medical devices Edition 1.1 2020-06 CONSOLIDATED VERSION, ISO 14971 Medical devices- Application of risk management to medical devices, 2019
Reported performance (0 observations)
FDA source did not state a quantitative performance metric — non-reporting is itself the signal.
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
- recall_reason_pattern
Software/algorithm-related recall in product code IYN (Philips Ultrasound, LLC, initiated 2025-10-31): "Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining." Recalling firm matches this device's applicant.
first seen 2026-07-08 · recall res_event_number:97843
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K253595 (decision 2026-03-27) from Philips Ultrasound, LLC for a matching device line ("EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K253595
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K251651 (decision 2025-10-09) from Philips Ultrasound, LLC for a matching device line ("EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K251651
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K251455 (decision 2025-07-24) from Philips Ultrasound LLC for a matching device line ("EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K251455
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K250886 (decision 2025-06-18) from Philips Ultrasound LLC for a matching device line ("EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K250886
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K243793 (decision 2025-05-21) from Philips Ultrasound LLC for a matching device line ("EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K243793
- …and 8 more.
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).